Amneal Pharmaceuticals, LLC recalls traMADol Hydrochloride Tablets
- Recalling company
- Amneal Pharmaceuticals, LLC
- Product
- traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal Pharmaceuticals LLC, Glasgow, KY 42141, NDC 60219-2348-5.
- Reason
- Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Mar 19, 2026
- Reported
- Apr 8, 2026
- Distribution
- Nationwide within the USA
- Status
- Ongoing
- Quantity
- 29,542 bottles
- Lot / codes
- Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026.
- Company location
- Bridgewater, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0408-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0408-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.